Randomized study between thymoglobulin and posttransplant cyclophosphamide in patients with chronic myeloid neoplasms undergoing unrelated allogeneic stem cell transplantation

Morozova, Еlena V.; Moiseev, Ivan S.; Vlasova, Yulia; Tsvetkov, Nikolai; Rudnitskaya, Yulia V.; Barabanschikova, Maria V.; Smirnova, Anna G.; Darskaya, Elena I.; Bondarenko, Sergey N.; Afanasyev, Boris

doi:10.18620/ctt-1866-8836-2020-9-1-53-59

Cited by 3 publications

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“…One randomized trial did not report any significant difference in the major outcomes of the 80 patients assigned to either PTCy or rATG prophylaxis in MUD or MRD alloSCT, however, the study was only presented at a conference, and lacked subgroup analysis for MUD alloSCT [ 6 ]. The other randomized trial was interrupted early after enrollment of 33 patients [ 7 ]. Several retrospective studies have investigated this question and one meta-analyses has pooled the results [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

ATG or post-transplant cyclophosphamide to prevent GVHD in matched unrelated stem cell transplantation?

Penack,

Abouqateb,

Peczynski

et al. 2024

Leukemia

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There is a high risk of GVHD and non-relapse mortality (NRM) after allogeneic stem cell transplantations (alloSCT) from unrelated donors. Prophylaxis with rabbit anti-thymocyte globulin (rATG) is standard in Europe but post-transplantation Cyclophosphamide (PTCy) is an emerging alternative. We analyzed outcomes of rATG (n = 7725) vs. PTCy (n = 1039) prophylaxis in adult patients with hematologic malignancies undergoing peripheral blood alloSCT from 10/10 antigen-matched unrelated donors (MUD) between January 2018 and June 2021 in the EBMT database. The provided P-values and hazard ratios (HR) are derived from multivariate analysis. Two years after alloSCT, NRM in the PTCy group was 12.1% vs. 16.4% in the rATG group; p = 0.016; HR 0.72. Relapse was less frequent after PTCy vs. rATG (22.8% vs. 26.6%; p = 0.046; HR 0.87). Overall survival after PTCy was higher (73.1% vs. 65.9%; p = 0.001, HR 0.82). Progression free survival was better after PTCy vs. rATG (64.9% vs. 57.2%; p < 0.001, HR 0.83). The incidence of chronic GVHD was lower after PTCy (28.4% vs. rATG 31.4%; p = 0.012; HR 0.77), whereas the incidence and severity of acute GVHD were not significantly different. GVHD-free relapse-free survival was significantly higher in the PTCy arm compared to the rATG arm (2 y incidence: 51% vs. 45%; HR: 0.86 [95% CI 0.75–0.99], p = 0.035). In the absence of evidence from randomized controlled trials, our findings support a preference for the use of PTCy in adult recipients of peripheral blood alloSCTs from MUD.

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Section: Introductionmentioning

confidence: 99%

ATG or post-transplant cyclophosphamide to prevent GVHD in matched unrelated stem cell transplantation?

Penack,

Abouqateb,

Peczynski

et al. 2024

Leukemia

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Prophylaxis and management of graft-versus-host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation

Penack,

Marchetti,

Aljurf

et al. 2024

The Lancet Haematology

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Allogeneic haematopoietic stem cell transplantation with reduced-intensity conditioning in chronic myeloid leukaemia

Morozova

Власова

Барабанщикова

et al. 2020

Gematologiâ i transfuziologiâ

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Introduction. Allogeneic haematopoietic stem cell transplantation (allo-HSCT) is the only curative therapy for chronic myeloid leukaemia (CML).Aim. Analysis of allo-HSCT outcomes in CML patients following reduced-intensity conditioning (RIC) regimens.Materials and methods. This retrospective study included 110 CML patients who underwent allo-HSCT in 1995–2019. RIC regimens included busulfan (8–12 mg/kg), ﬂudarabine (180 mg/m2) or melphalan (140 mg/m2), ﬂudarabine (180 mg/m2). The median onset time for treatment with tyrosine kinase inhibitors (TKIs) was 60 days after allo-HSCT (30–835). Post-transplant graft-versus-host-disease (GVHD) prevention with cyclophosphamide (Cy) at high doses (PTCy) of 50 mg/kg in 3–4 days after allo-HSCT (D+3, D+4) was ordered in 61 % (n = 67), with antithymocyte globulin (ATGAM) 60 mg/kg — in 17 % (n = 19), with thymoglobulin 5 mg/kg — in 3 % (n = 3) of the patients.Results. In the study cohort, 50 % (n = 55) of the patients had chronic phase 2 and higher (CP ≥ 2), 25 % (n = 27) — accelerated phase (AP), 9 % (n = 10) — blast crisis (BC) phase of the disease. Among CP ≥ 2 patients, 63 % (n = 58) had a BC in history, and 25 % (n = 23) — 2 or more BCs. One-year non-relapse mortality (NRM) was 21 % (95 % CI 15–31). PTCy prevention of GVHD signiﬁcantly reduced the NRM risk relative to other schemes: 11 % (95 % CI 5–20) vs. 38 % (95 % CI 23–53) (p = 0.001). Acute GVHD II–IV had a rate of 23 % (95 % CI 15–31), chronic GVHD of moderate to severe degree 15 % (95 % CI 9–22). TKIs were used in 49 % (n = 29) cases for relapse prevention, in 40 % (n = 24) — due to the lack of response to allo-HSCT, in 10 % (n = 6) — in relapse. Donor lymphocyte infusion (DLI) was performed in 37 patients mainly in BCR-ABL positive cases (24 %, n = 9) and relapse (49 %, n = 18). Three-year relapse rate was 36 % (95 % CI 26–46), and ﬁve-year relapse-free survival (RFS) was 40 % (95 % CI 29–51). Transplantation in AP or BC phase signiﬁcantly increased the relapse rate (odds ratio 2.4800 (1.2180–5.050), p = 0.012). Five-year overall survival was 52 % (95 % CI 40–62), a clean BC history and PTCy correlated with a higher 5-year overall survival (odds ratios 1.9990 (1.0700–3.7350), p = 0.029, and 0.3126 (0.1670–0.5851), p = 0.0002, respectively).Conclusion. Reduced-intensity conditioning is advantageous in patients with long-term CML and several lines of TKI therapy in history. Post-transplant complication relief is associated with PTCy prevention. Relapse instances, however, complicate the outcomes of allo-HSCT with RIC. Post-transplant TKI and DLI facilitate response in 54 % of the patients. Success of allo-HSCT largely depends on the disease phase (CP, AP, BC) at the time of transplantation.

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Randomized study between thymoglobulin and posttransplant cyclophosphamide in patients with chronic myeloid neoplasms undergoing unrelated allogeneic stem cell transplantation

Cited by 3 publications

References 0 publications

ATG or post-transplant cyclophosphamide to prevent GVHD in matched unrelated stem cell transplantation?

ATG or post-transplant cyclophosphamide to prevent GVHD in matched unrelated stem cell transplantation?

Prophylaxis and management of graft-versus-host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation

Allogeneic haematopoietic stem cell transplantation with reduced-intensity conditioning in chronic myeloid leukaemia

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